Study Start-Up Specialist Manager

Introduction :

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates.

Our unique one-stop provider service model leveraging full-service, functional service provider and consulting allows our Excelyates to evolve through a diverse array of projects.

In collaboration with preeminent experts, Excelya advances scientific, managerial, and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field.

We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

To learn more about us, visit www.excelya.com

Mission

• The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the Client’s procedures, documents, local and international guidelines such as ICH GCP and relevant regulations.
• The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
• The SSU manager works in close collaboration with the CRAs and the Local Study Team / Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.
• SSU Manager might have different internal titles based on the experience level (SSU Manager, Senior SSU Manager).
• The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues.

Profile

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations, basic knowledge of GMP / GDP
• Basic understanding of drug development process
• Excellent understanding of Clinical Study Management and study start-up
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
Il y a 28 jours